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Dr. Janet Woodcock of U.S. Food and Drug Administration to be presented with first Leadership in Personalized Medicine Award

— Inaugural award to be presented November 3 at personalized medicine conference —

BOSTON, MA - Nov. 3, 2005 — For her pioneering role in advancing personalized medicine through programs such as the Critical Path Initiative and the Guidance on Pharmacogenomic Data Submissions, Dr. Janet Woodcock, Deputy Commissioner of Operations and Chief Operating Officer, U.S. Food and Drug Administration (FDA), will be honored by the Personalized Medicine Coalition (PMC) with the first Leadership in Personalized Medicine Award.

The Leadership Award recognizes the contributions of a visionary individual whose actions in science, business, or policy have advanced the frontier of personalized medicine. Dr. Woodcock will accept the award during a reception at the Harvard-Partners Center for Genetics and Genomics (HPCGG) conference, Personalized Medicine: Promises and Prospects, in Boston, MA, on Thursday, November 3 at 5:00 p.m. (http://www.hpcgg.org/News/program.jsp).

Personalized medicine refers to using methods of molecular analysis to better manage disease or predisposition toward disease. It aims to achieve optimal medical outcomes by helping physicians and patients choose among the disease management approaches likely to work best in the context of a patient's genetic and environmental profile.

"We are pleased to present this award to Dr. Woodcock for her dedication to promoting personalized medicine," said PMC Executive Director Edward Abrahams. "Through her determined initiative to introduce pharmacogenomics into the drug approval process, Dr. Woodcock has linked innovation to regulation in an effort to bring safer and more effective drugs to the American public."

"Janet Woodcock exemplifies the leadership we need from the FDA to make personalized medicine a reality," said PMC Board Member Mara Aspinall, president, Genzyme Genetics. "Dr. Woodcock's leadership is helping us move closer to the day when every patient will get the right test at the right time."

The Guidance on Pharmacogenomic Data Submissions, which Dr. Woodcock directed, was issued in March 2005 to guide the timing and content of submissions to the FDA for pharmacogenomic-derived investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs). In addition, the Guidance is designed to provide information on how and when data will be used in regulatory decision-making. The Guidance also established a framework for voluntary submission of genomic data.

The Guidance was a significant step in setting the stage for a new era in health care — the era of personalized medicine. Upon release of the guidelines, Dr. Woodcock noted that "FDA's efforts will bring us one step closer to 'personalizing' medical treatment."

The Critical Path Initiative was proposed in 2004 in response to a decline in the number of potential medical therapies being submitted to the FDA for approval despite noticeable advances in innovation and technological breakthroughs. In order to match rapidly advancing research to acceleration in product development, the initiative focuses on improving scientific efforts in order to modernize the techniques and methods used to evaluate the safety, efficacy, and quality of medical products as they move from product selection and design to mass manufacture.

"Janet Woodcock has been a beacon for personalized medicine," said PMC Board Member Dr. Geoffrey Ginsburg, director of the Center for Genomic Medicine, Institute for Genome Sciences & Policy at Duke University and chair of the ad hoc selection committee for the Leadership Award. "Her leadership at the FDA, exemplified by her challenge to the pharmaceutical industry to develop innovative and tailored therapies, has been truly catalytic in bringing valuable genomic information to health and society."

About the Personalized Medicine Coalition
The Personalized Medicine Coalition (PMC) is a non-profit group dedicated to advancing the understanding and adoption of personalized medicine concepts and products for the ultimate benefit of patients. PMC membership encompasses a broad spectrum of academic, industrial, patient, and health care provider constituencies. For more information on the Personalized Medicine Coalition, please visit www.personalizedmedicinecoalition.org.

Contact:
Megha Satyanarayana
Feinstein Kean Healthcare
Phone: (617) 761-6791
Email: megha.satyanarayana@fkhealth.com